Regulatory Affairs Specialist Jobs in Annapolis, MD
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Annapolis, MD
- 2 days ago
- Annapolis, MD
- 2 days ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Sr Principal International Trade Compliance Analyst
- Linthicum, MD (16 miles from Annapolis, MD)
- 7 days ago
- Linthicum, MD (16 miles from Annapolis, MD)
- 7 days ago
RELOCATION ASSISTANCE: No relocation assistance availableCLEARANCE TYPE: NoneTRAVEL: Yes, 10% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work on...
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
- Elkridge, MD (17 miles from Annapolis, MD)
- 45+ days ago
- Elkridge, MD (17 miles from Annapolis, MD)
- 45+ days ago
Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace...
- Linthicum Heights, MD (16 miles from Annapolis, MD)
- 45+ days ago
- Linthicum Heights, MD (16 miles from Annapolis, MD)
- 45+ days ago
Audit. c....
- Linthicum Heights, MD (16 miles from Annapolis, MD)
- 45+ days ago
- Linthicum Heights, MD (16 miles from Annapolis, MD)
- 45+ days ago
Audit. c....
Demographic Data for Annapolis, MD
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Annapolis, MD
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Annapolis, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Medicare
- Internal Control
- Management Reporting
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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